Inclusion of women in clinical trials

BMC Medicine

Volumn 7, Issue , 2009, Pages 56-

  Berlin, Jesse A ^a   Ellenberg, Susan S ^b  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL RESEARCH; CLINICAL STUDY; DRUG APPROVAL; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; FEMALE PHYSICIAN; FETOPLACENTAL UNIT; GENDER BIAS; GENE EXPRESSION; HEALTH CARE POLICY; HIGH RISK POPULATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; METHODOLOGY; PATIENT SELECTION; PHYSICIAN ATTITUDE; RISK BENEFIT ANALYSIS; SEX DIFFERENCE; WOMEN'S HEALTH;

EID: 70449515056     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/1741-7015-7-56     Document Type: Article

References (19)

1. The Multiple Risk Factor Intervention Trial Group Statistical design considerations in the NHLI multiple risk factor intervention trial (MRFIT). J Chronic Dis 1977, 30(5):261-275. 10.1016/0021-9681(77)90013-3, 863996.
2. Multiple Risk Factor Intervention Trial Research Group Multiple risk factor intervention trial. Risk factor changes and mortality results. JAMA 1982, 248(12):1465-1477. 10.1001/jama.248.12.1465, 7050440.
3. Hennekens CH, Eberlein K. A randomized trial of aspirin and beta-carotene among U.S. physicians. Prev Med 1985, 14(2):165-168. 10.1016/0091-7435(85)90031-3, 3900975.
4. Hennekens CH, Buring JE. Methodological considerations in the design and conduct of randomized trials: the U.S. Physicians' Health Study. Control Clin Trials 1989, 10(4 Suppl):142S-150S. 10.1016/0197-2456(89)90053-6, 2605963.
5. Healy B, Healy B. The Yentl syndrome. N Engl J Med 1991, 325(4):274-276.
6. Merkatz RB. Women in clinical trials: an introduction. Food Drug Law J 1993, 48(2):161-166.
7. Gorenberg H, White A. Off the pedestal and into the arena: toward including women in experimental protocols. Rev Law Soc Change 1991, 19(1):205-246.
8. Meinert CL, Gilpin AK, Unalp A, Dawson C. Gender representation in trials. Control Clin Trials 2000, 21(5):462-475. 10.1016/S0197-2456(00)00086-6, 11018563.
9. NIH Revitalization Act, Subtitle B. Part 1. 1993, 131-133.
10. Merkatz RB, Junod SW. Historical background of changes in FDA policy on the study and evaluation of drugs in women. Acad Med 1994, 69(9):703-707. 10.1097/00001888-199409000-00004, 8074759.
11. Gowen A. Pregnant Women in D.C. Area Cautious About Flu Shot. Washington Post 2009,
12. Freedman LS, Simon R, Foulkes MA, Friedman L, Geller NL, Gordon DJ, Mowery R. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993--the perspective of NIH clinical trialists. Control Clin Trials 16(5):277-285. 293, 10.1016/0197-2456(95)00048-8, 8582146.
13. Fisher B, Wolmark N, Rockette H, Redmond C, Deutsch M, Wickerham DL, Fisher ER, Caplan R, Jones J, Lerner H. Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer results from NSABP protocol R-01. J Natl Cancer Inst 1988, 80(1):21-29. 10.1093/jnci/80.1.21, 3276900.
14. Hamilton J, Hartigan P, Simberkoff M, . Veterans Affairs Cooperative Study Early vs later zidovudine treatment of symptomatic HIV infection (abstr.). Clin Res 1991,
15. Lagakos S, Fischl MA, Stein DS, Lim L, Volberding P. Effects of zidovudine therapy in minority and other subpopulations with early HIV infection. JAMA 1991, 266(19):2709-2712. 10.1001/jama.266.19.2709, 1942422.
16. Temple R, Stockbridge NL. BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective. Ann Intern Med 2007, 146(1):57-62.
17. Bibbins-Domingo K, Fernandez A. BiDil for heart failure in black patients: implications of the U.S. Food and Drug Administration approval. Ann Intern Med 2007, 146(1):52-56. [erratum appears in Ann Intern Med. 2007; Apr 17;146(8):616].
18. NIH Comprehensive Report: Tracking of Human Subjects Research As Reported in Fiscal Year 2006 and Fiscal Year. , http://orwh.od.nih.gov/inclusion/finalannualreport2007.pdf
19. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA 2004, 291(22):2720-2726. 10.1001/jama.291.22.2720, 15187053.